immunogenicity and safety of menactra® vaccine in subjects aged 9 to 23 months in india and in the russian federation

Conditions: Meningitis; Meningococcal Infection

Summary: the purpose of this study is to assess the immunogenicity and safety of menactra® vaccine given as a two-dose series in infants and toddlers. primary objectives: * to assess the seroprotection rate (percentage of subjects with a serum bactericidal assay using human complement \[sba-hc\] titer ≥ 1:8) 28 days after the second of 2 doses of menactra® administered 3 to 6 months apart. secondary objectives: * to assess the immune responses to meningococcal antigens (serogroups a, c, y, and w-135) 28 days following the second vaccination with menactra® using sba-hc and sba-br titers. * to assess the safety profile of menactra® after each and any vaccination.

study participants will receive 2 doses on menactra® vaccine at 3 to 6 months apart and will be monitored for safety and immunogenicity. the planned duration of each subject's participation in the trial will be from 118 to 215 days.

Eligibility criteria:
inclusion criteria: * male and female subjects aged 9 to 17 months on the day of inclusion * informed consent form has been signed and dated by the parent(s) or other legally acceptable representative(s) (if applicable) * subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria: * participation in the 4 weeks preceding inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination, except for: * (i) influenza vaccination, which may be received at least 2 weeks before study vaccines. * (ii) measles (m) or measles, mumps, rubella (mmr) routine vaccination, which can be administered concomitantly with the first dose of study vaccine as per routine immunization schedule * (iii) for subjects enrolled at indian sites: oral poliomyelitis vaccine (opv) received during national immunization days (nids) and supplementary immunization activity days (siads) * previous vaccination against meningococcal disease with either the study vaccine or another meningococcal vaccine * receipt of immune globulins, blood or blood-derived products in the past 3 months * known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * history of meningococcal diseases, confirmed either clinically, serologically, or microbiologically * at high risk, in the opinion of the investigator, for meningococcal disease during the trial * known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances * known thrombocytopenia, contraindicating intramuscular vaccination * bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination * in an emergency setting, or hospitalized involuntarily * chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * for subjects enrolled at indian sites: moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°c). * for subjects enrolled at russian sites: acute disease of any severity on the day of vaccination or febrile illness (axillary temperature ≥ 37.0°c). a prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. * receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw * identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study * personal history of guillain-barré syndrome.

Keywords: meningitis meningococcal infection menactra®